Kornimate/medical-research-clean huggingface dataset:
a randomized controlled trial comparing surgical decompression with an interlaminar implant in patients with intermittent neurogenic claudication caused by lumbar stenosis

Conditions: Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

Summary: a randomized, blinded comparison of surgical intervention with the coflex® interspinous implant versus surgical decompression for patients with intermittent neurogenic claudication caused by lumbar stenosis

in this investigation, it will be investigated whether the effectiveness of surgical intervention with coflex® is equivalent to surgical decompression after 12 months in people with intermittent claudication. the main advantage of coflex® might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect remains. therefore in addition, it will be investigated whether surgical intervention with coflex® is more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and whether surgical intervention with coflex® is more cost-effective after 12 months than surgical decompression.

Eligibility criteria:
inclusion criteria: * signed informed consent * is 40 to 85 years old at time of surgery * has inc, as noted by leg/buttock/groin pain with or without back pain. leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting in a chair * has received at least three months of conservative care therapy which may have included, but is not limited to, physical therapy, bracing, systemic and/or injected medications * has a regular indication for surgical intervention of inc * has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by mri * is physically and mentally willing and able to comply with, or has a caregiver who is willing and able to comply with, the post-operative evaluations. exclusion criteria: * has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence) * has paget's disease, severe osteoporosis or metastasis to the vertebrae * has significant scoliosis (cobb angle \> 25 degrees) * has a body mass index (bmi) \> 40 kg/m2 * has had any surgery of the lumbar spine * has degenerative spondylolisthesis \> grade 1 (on a scale 1 to 4) at the affected level * has significant instability of the lumbar spine * has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study * has a fused segment at the indicated level. * has a herniated disk on the level of interest
postmarketing clinical trial of tdcs to evaluate cognitive ability in depression patients

Conditions: Depression

Summary: this study is a multicenter, double-blind, randomized, and confirmed clinical trial in patients taking antidepressants during the 6-week stimulation period , sham stimulation group, low real stimulation group (1ma), high real stimulation group (2ma) and treatment every day for 6 weeks (a total of 42 times). as a primary outcome, the investigator analyze the improvement effect of working memory ability, and confirm whether the effects of anxiety and depression are improved by the secondary outcome, together with the quality of life evaluation.

during the clinical trial period, a total of 4 to 5 outpatient visits are made, and changes are evaluated through neuropsychological examination by visiting at 2, 4 and 6 weeks based on the baseline time point. in addition, in the case of patients who agree after 6 weeks of participation, an additional 6 weeks of high real stimulation is used to conduct an open extension study.

Eligibility criteria:
inclusion criteria: 1. diagnosis of major depressive disorder 2. cgi severity (severity of illness) score of 3 or higher 3. patients receiving medication for depression at the time of study participation 4. those who can read and understand the subject's explanation and consent form and who can respond to questionnaires exclusion criteria: 1. history of clinically significant medical neurological disease or history of head injury 2. in case of mental retardation or cognitive impairment enough to affect the writing of consent form or conducting research 3. severe suicidal risk or psychotic symptoms determined by the clinician 4. in the case of a contraindication to the implementation of tdcs (when a metallic auxiliary tool is inserted in the head) 5. those who are judged to have problems with the attachment of eeg and dc stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems at the electrode attachment site 6. among female subjects who are likely to become pregnant, those who do not agree to contraception by a medically acceptable method for up to 24 weeks after application of the investigational medical device in this clinical trial 7. pregnant women 8. any other person who has reasons to judge that the investigator is unsuitable for participation in the clinical trial
comparison between two different protocols of negative pressure therapy for healing of chronic ulcers

Conditions: Chronic Ulcers; Negative Pressure Therapy

Summary: negative pressure wound therapy (npwt), is a non invasive wound management tool which develops from negative pressure being applied to the wound. this promotes healing through the removal of infectious materials and enhancing granulation tissue formation. npwt eases debridement as well as promoting healing of different types of wounds.

assessment of wound surface area was done by a graded plastic sheet and a metric graph paper, by counting the complete squares of the metric graph paper, while the wound size was done by using a 10 cm syringe filled with dermazin cream and filling the wound with it. negative pressure device: vac system 125mmhg (kci negative pressure equipment). wound surface area tracing tools: * sterilized transparent film. * fine tipped transparent marker. * carbon and a white a4 papers. * metric graph paper (1mm²). wound volume assessment procedure: * using a syringe of ten cubic centimeters filled with dermazin cream. * the wound is filled with the cream * the amount of cream injected into the wound was detected in cubic centimeters.

Eligibility criteria:
inclusion criteria: * they were free from immune deficiency diseases or collagen diseases. * all patients were homeostasis. * all patients were medically stable. * all cases were chronic and did not heal with other treatment methods exclusion criteria: * 1. malignancies or receiving radiotherapy. 2. dermatological diseases. 3. deep venous thrombosis. 4. renal failure. 5. immunosuppressant or anticonvulsants therapies.
a randomised controlled clinical trial of memory specificity training (mest) for depression

Conditions: Major Depressive Disorder; Depressive Symptoms

Summary: depression involves the tendency to recall overgeneral personal memories, a phenomenon which has been linked to numerous adverse psychological outcomes. the purpose of this study is to investigate whether a group-based memory specificity training (mest) programme improves outcomes in depression, and how this compares to an education and support control group. the primary aim is to examine whether mest, which involves repeated practice retrieving specific autobiographical memories reduces depressive symptoms immediately post-treatment, and whether this is maintained 3 months after treatment. the secondary objective of this trial is to examine the role of hypothesised cognitive processes (ie., rumination, executive control, cognitive avoidance) which may underlie improvements in depression and memory.


Eligibility criteria:
inclusion criteria: * principal diagnosis of major depressive disorder * history of more than one previous depressive episode * current diagnosis of a major depressive episode * depressive symptoms rated in the mild-severe range (\> 13 on the bdi-ii) * memory specificity \< .70 (as assessed on the amt) exclusion criteria: * head trauma * organic brain damage * secondary diagnosis of another affective disorder * psychosis * current drug or alcohol abuse or dependence * a diagnosed axis ii disorder

Keywords: memory specificity training autobiographical memory major depressive disorder
prospective registry of outcomes and management of acute ischaemic syndromes

Conditions: Acute Coronary Syndromes; Coronary Artery Disease

Summary: this is a multi-centre uk study designed to evaluate if an educational intervention programme delivered to health care professionals can improve the use of evidence based treatments in the management of patients admitted to hospital with non-st elevation acute coronary syndrome. a total of 38 centres participated, half received the educational intervention. patients were followed to hospital discharge. patients were followed up at 6 months. longer term follow up through the office of national statistics will be performed.

this is a multi-centre uk study designed to evaluate if an educational intervention programme delivered to health care professionals can improve the use of evidence based treatments in the management of patients admitted to hospital with non-st elevation acute coronary syndrome. a total of 38 centres participated. a cluster randomised method was used and half of centres received the educational intervention. patients were followed to hospital discharge. patients were followed up at 6 months and longer term follow up for mortality will be performed through the national databases.

Eligibility criteria:
inclusion criteria:all patients admitted to the hospital (either through casualty or directly to the wards), with a good clinical history of an acute coronary syndrome with one or more of the following: 1. ischaemic changes on the admission ecg (including patients with bundle branch block) 2. elevated troponin or cardiac enzymes on admission 3. normal ecgs but with evidence of pre-existing coronary artery disease i.e., evidence of a prior history of mi, coronary revascularisation, coronary angiography demonstrating the presence of significant coronary stenosis or a stress test demonstrating ischaemia (treadmill, echo or nuclear scan) written informed consent exclusion criteria: 1. patients with persistent st elevation \>1mm in two or more contiguous leads on the ecg. 2. patients treated with thrombolytic therapy, or for whom thrombolytic therapy was considered on admission.

Keywords: non-st elevation acute coronary syndrome educational intervention evidence based practice guidelines
a study of emibetuzumab in non small cell lung cancer (nsclc) participants

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the primary purpose of this study is to evaluate the efficacy of the study drug known as ly2875358, administered alone or in combination with a second drug named erlotinib, in participants affected by a defined type of lung cancer (met biomarker diagnostic positive non-small-cell lung cancer) that experienced a disease progression during the most recent treatment with erlotinib.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic stage iv nsclc * at least 1 measurable extra-central nervous system (cns) lesion * documented radiographic progression while on continuous treatment with erlotinib monotherapy * objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (egfrmt) status, at least 12 weeks stable disease * determined to be met diagnostic positive (+) * availability of a tumor sample post-erlotinib progression * eastern cooperative oncology group (ecog) performance status ≤2 * have adequate organ function exclusion criteria: * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device * have previously been treated with ly2875358 or any other met-targeting experimental therapeutic * have a serious concomitant systemic disorder or significant cardiac disease * have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently * have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study * have major surgery less than 2 weeks prior initiation of study treatment therapy * pregnant or lactating women * have symptomatic cns metastasis
recurrence rate and esthetic outcome after excision of basal cell carcinomas excluded from trial nct00515970

Conditions: Carcinoma, Basal Cell

Summary: currently, we conduct a prospective, randomized trial comparing the outcome of surgical excision with the outcome of curettage in nodular and superficial bccs. larger bccs and micronodular or sclerosing bccs are not included in the randomized study. they are mainly operated using three-dimensional histology (3d-histology, micrographic surgery). in this observational study we measure the cosmetic result and the recurrence rate of all bccs not included in the randomized trial.

1. disinfection 2. local anesthesia 3. surgery 4. dressing 5. preparation with paraffin for histopathologic evaluation 6. staining with hematoxylin-eosin 7. adjuvant radiotherapy is not applied in any of our patients. 8. if histopathology discovers another tumor than bcc, the tumor is excluded. 9. if recurrence is suspected, a punch biopsy is taken. if recurrence is confirmed, the endpoint is achieved. 10. patients who provide no feedback receive phone calls. 11. the patient receives a letter containing a list of the bccs treated within the study. she or he is asked to visit the private practitioner with the list after 12 and 48 months (+/- 30 days) referring to the last operation in the recruitment period. the practitioner or the patient return the questionnaire to our department. 12. the letter contains a questionnaire about suspicion of recurrence of bcc. 13. the patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor. 14. the physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor. 15. when follow-up is closed for an individual patient, the reason is recorded: 1. planned end of follow-up after 48 months 2. patient has moved. 3. death (date of death) 4. consent withdrawn 5. meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned. 6. recurrence of all of the patient's bccs with histopathologic confirmation.

Eligibility criteria:
inclusion criteria: * bccs excluded from the randomized trial nct00515970 exclusion criteria: * treatment other than with 3d-histology or shave excision (e.g. deep surgical excision without 3d-histology)

Keywords: carcinoma, basal cell 3d-histology micrographic surgery mohs surgery shave excision recurrence esthetic outcome
altshock-2 registry

Conditions: Cardiogenic Shock

Summary: the study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the intensive coronary care units

cardiogenic shock (cs) is the most severe form of acute heart failure. data on epidemiology of cs have been drawn from previously published registries focussing on acute coronary syndrome (acs) and myocardial infarction (ami). indeed, cs occurs in 5-7% of patients presenting with acs and acs has been reported as the most prevalent cause of cs, accounting for about 80% of cases. however, recent evidences in a contemporary cohort in north america have shown that more than two-thirds of all cardiogenic shock cases were related to causes other than ami and that these patients had outcomes at least as poor as patients with ami-cs. given the high short-term mortality of these patients and the need for developing dedicated cardiac shock centres and systems of care to time our interventions, it is of utmost importance to achieve a better clinical phenotyping of the heterogeneous causes and presentations of cs patients and carefully perform research outcome. accordingly, the altshock-2 registry will represent a unique opportunity to evaluate the full spectrum of cs admitted in intensive coronary care units and to collect a selected number of variables related to aetiology, clinical presentation, ongoing pharmacological treatments, use of mechanical support devices and outcome.

Eligibility criteria:
all consecutive cs patients hospitalized in the above reported centres between january 2020 and december 2030. cardiogenic shock is defined as: 1. systolic blood pressure (sbp) \ 90 mmhg or map \> 60 mmhg, or need of mcs; 2. at least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \ 2 mmol/l; oliguria \< 0.5 ml/kg/h for at least 6 hours.

Keywords: cardiogenic shock
effect of calcium- d supplement on hypertension

Conditions: Hypertension

Summary: triple-blind randomized clinical trial was done on 98 hypertensive women of postmenopausal ages in 2019. the study was executed for 8 weeks with close follow up and , 24-hour ambulatory blood pressure monitoring (abpm) was used to record the initial and final blood pressures of all participants. patients were randomized to calcium-d supplement and placebo

triple-blind randomized clinical trial were performed on 98 hypertensive women of postmenopausal ages in 2019. they were randomly divided into a control group of 50 members and a treatment group of 48 members. randomization was based on block randomization method with block size=2 and ratio 2:2 for drug and placebo. to achieve triple blinding, patients were divided into "a" and "b" groups(by the mentioned randomization method). "a" was assigned to treatment and "b" to placebo but this assignment was not revealed to the patients, trial conductors and result assessors till the end of data analysis. oral calcium-d supplements were given to the treatment group in the form of tablets named vana flex® from vana darou gostar co. (vdg co.). each tablet contained 500 milligrams of calcium carbonate and 200 international units (iu) of vitamin d3(cholecalciferol). the placebo pills for the control group were chose in a way that looked similar to the calcium-d tablets in shape and color. the placebo tablets we used in this trial were made up of magnesium stearate 0.2 %, starch 10%, avicel 30%, and lactose 60%. the calcium-d and placebo tablets were both packed identically in order to assure blindness and the patients were told to take one tablet per day. the treatment and placebo group started drugs beside their previous hypertension medications. 24-hour ambulatory blood pressure monitoring (abpm) was done primarily for all of the participants to record the initial blood pressure of patients and after completion of study period

Eligibility criteria:
inclusion criteria: * postmenopausal female with hypertension * receiving antihypertensive drugs exclusion criteria: * history of coronary artery disease * congestive heart failure * chronic renal disease * hypercalcemia * nephrolithiasis * any other contraindications of calcium use

Keywords: hypertension calcium-d ambulatory blood pressure monitoring
the effectiveness of deep brain stimulation for opioid relapse prevention

Conditions: Opiate Addiction

Summary: the nucleus accumbens (nacc) has a significant role in the process of opiate addiction and the initiation of relapse after detoxification. there is evidence that deep brain stimulation (dbs) of the nacc exerts a positive effect on individuals with severe heroin addiction via inhibitory action . the investigators hypothesise that bilateral stimulation of the nacc will significantly reduce withdrawal symptoms and thus enable the patients to substantially decrease their levomethadone usage.


Eligibility criteria:
inclusion criteria: * proficiency in mandarin language * long lasting heroin addiction (determined by diagnostic-criteria in diagnostic and statistical manual of mental disorders, fifth edition) * duration longer than 6 months * a lack of response to long-term treatment * capacity to provide informed consent (understanding of the study purpose and methods) * substitution methadone treatment at a constant dose within three months prior to inclusion. exclusion criteria: * clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases with psychotic symptoms)(mini 6.0) * past stereotactic neurosurgical intervention * neurological disease (abnormal pet-ct, mri, eeg) * contraindications of mri-examination, e.g. implanted cardiac pacemaker/ heart defibrillator * contraindications of stereotactic intervention, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases) * serious and unstable organic diseases (e.g. unstable coronal heart disease) * hiv positive * pregnancy and/or lactation
effectiveness of a multi-component physical training in hyper-fragile elders: a randomized clinical trial

Conditions: Multimodal Intervention; Fragility; Other Metabolic Diseases; Physical Activity; Patient Fall; Dietary Modification

Summary: objective: to compare short-term and medium-term effectiveness of a multimodal program that integrates a program of therapeutic exercise, medication review, adequacy of diet and health education, compared with standard medical practice in improving neuromuscular and physiological status on frail elderly. another aim is to analyze the maintenance of these effects by monitoring long-term (12 months) from the start of the intervention. design: randomized controlled trial scope / study subjects: recruited frail elderly in basic health zone of malaga. methods: the subjects to be included in the study (after meeting inclusion / exclusion) will be randomized into two groups: a control group whose intervention will be to review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles) and an experimental group whose intervention will be a multimodal intervention: therapeutic exercise + review medication + adequacy of diet + health education program. sociodemographic, clinical and monitoring variables will be collected at baseline. moreover, tracking variables will be collected at 2 and 6 months after starting the intervention and at 3 and 6 months after the end of the intervention (monitoring). the monitoring variables that will be measured are: bmi , general health, fatigue, brittleness, motor control, attention - concentration - memory, motor memory , spatial orientation, grip strength, balance (static - semi-static and dynamic ), gait speed and metabolomic variables. one descriptive analysis of the sociodemographic variables of the participants will be performed. further the change on the variables intra-subjects (pre-post intervention) and inter-subjects (experimental group vs control group) will be calculated. for the intra-subject analysis will be performed a anova-one factor analysis. the intersubject outcome variables will be compared between the two groups in each moments of data collection, using the student t-test or wilconxon (depending of the sample distribution). the level of significance was set at p ≤ 0.05.


Eligibility criteria:
inclusion criteria: * people 65 years older than after screening of fragility as the test battery short physical performance battery (sppb), can perform the therapeutic exercise program exclusion criteria: * presence in the medical history of neuromuscular , metabolic, hormonal and / or cardiovascular disorders.